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FDA 510(k)

Vitavitro 液化儀器組合包、Vitavitro 加熱儀器組合包以及Vitavitro 管子組

K 號：K180073 · 2018-08-29

申請人Shenzhen Vitavitro Bio-Tech Co., Ltd.
決定日期2018-08-29
產品代碼MQL
諮詢委員會OB設備之醫療設備規範文本翻譯如下： 關於OB設備的醫療設備規範文件： 此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址： 識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1
決定相當於

器材摘要

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vitavitro Bio-Tech Co., Ltd.. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K180073. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set?

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Shenzhen Vitavitro Bio-Tech Co., Ltd.. The 510(k) number is K180073.

When did Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set receive FDA 510(k) clearance?

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set received FDA 510(k) clearance on 2018-08-29, under 510(k) number K180073.

Who is the listed applicant for Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set?

The FDA 510(k) record lists Shenzhen Vitavitro Bio-Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set?

The FDA product code for Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set is MQL.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：MQL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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